dr. s k singh
TRANSCRIPT
Dr. S. K. SinghM. Sc.(Chemistry) Ph.D.
Over 25 years of experience in Quality System, Quality Operations, Stability Studies, Regularity Compliance & Tech. Services in Pharmaceuticals & Herbal Preparations
E-mail ID: [email protected] Blog: www.drsanjaykumarsingh.blogspot.com
Skype: drsingh906Contact No: +91 9158840329
EXPERTISE Validations: URS, DQ, IQ, OQ & PQ.
Process Validation.Analytical Method validation.Cleaning validation. Water System validation.Research Stability Studies (RSS).
New Product Development & Tech. transfer
Audit Risk Assessment. Training Inspection & Approval of Third Party /
Contract Manufacturing/Analysis. Implementation of Quality Management System as per ISO/IC 17025
& Schedule M
A new project…
Laboratory Layout R&D Design Production Equipment-Selection Laboratory Instruments-Selection Qualification & Validation SOPs HVAC System Water Purification System
FACILITIES Formulation Development. Analytical Method Development. Wet Chemistry lab. Instrument Analysis Room Packaging Development Lab Packaging Analysis Lab. Hot Room Chemical Storage Room Microbiology Lab Control Sample Room Document control & Document issuance room
ACTIVITIES
Qualification DocumentsUser requirement specificationsDesign QualificationFactory Acceptance testSite Acceptance testInstallation QualificationOperational QualificationProcess Qualification ( Performance Qualification)SOPs TrainingTechnology Transfer
VALIDATION/QUALIFICATION
Prospective Validation Concurrent Validation Analytical Method
Validation Cleaning Validation Water System Validation HVAC Validation
Area/Facilities Qualification Personal Qualification Vender Qualification
STUDIES
Hold time Studies of clean equipment Hold time Studies of in process product ( Bulk Products) Studies of temperature and Humidity in Storage and processing Area Bio-Burden Studies of critical processing Area Equipment-cleaning in place (CIP) & cleaning out of place (COP) Stabilities Studies of finished product
DODGES FORM Tablets Capsules Oral Liquids External Preparations, Liquid, Cream & Ointment Sterile Preparations (Eye drops, Injectable & Ointment) Oral Hygiene Product (Medicated Toothpaste, Dental get, Mouth Washes) Herbal Preparations (Tablets, Capsules & Powders)
Thank You